How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?

NCT06614933 | Completed FDA Device

• 1 other identifier: 20240796
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Tolerability measured by tolerability questionnaire

  Tolerability will be assessed with a questionnaire with scores ranging from 0 (no discomfort)-10 (worst pain imaginable) for comfort.

  Up to 3 hours.

• Tolerability measured by self-report

  Tolerability will be assessed using semi-structured interviews. Investigators will ask about the sensations experienced and preferences. Participants will self-report their responses.

  Up to 3 hours.

Secondary Outcomes (1)

• Change in heart rate variability (HRV)

  Baseline and up to 3 hours.

Study Arms (2)

Biphasic followed by monophasic taVNS group

EXPERIMENTAL

Participants in the group "Biphasic followed by monophasic taVNS" will be in this group for up to 6 hours.

Device: Biphasic transcutaneous auricular vagus nerve stimulation; Device: Monophasic transcutaneous auricular vagus nerve stimulation

Monophasic followed by biphasic taVNS group

ACTIVE COMPARATOR

Participants in the group "monophasic followed by biphasic" will be in this group for up to 6 hours.

Device: Biphasic transcutaneous auricular vagus nerve stimulation; Device: Monophasic transcutaneous auricular vagus nerve stimulation

Interventions

Biphasic transcutaneous auricular vagus nerve stimulation DEVICE

Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN). Participants in this group will first receive taVNS with a biphasic current, continuous at 25 Hz, for 1 hour, in-person.

Biphasic followed by monophasic taVNS group; Monophasic followed by biphasic taVNS group

Monophasic transcutaneous auricular vagus nerve stimulation DEVICE

Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN). Participants in this group will first receive taVNS with a monophasic current, with a 50% duty cycle at 25 Hz, for 1-hour, in-person.

Biphasic followed by monophasic taVNS group; Monophasic followed by biphasic taVNS group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between the ages of 18-80 years
• English speaking (must be able to consent and complete the interviews in English)

You may not qualify if:

• chronic pain (average intensity \>2/10 on 0-10 scale, for longer than 3 months)
• acute pain of intensity greater than 3/10
• chronic inflammatory conditions that are poorly controlled (e.g., diabetes, autoimmune disease)
• any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia)
• pregnancy
• currently taking Buprenorphine or recently stopped taking (within 1 month)
• presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews
• implants in the head or neck, cochlear implants, or pacemaker
• head or neck metastasis or recent ear trauma
• history of epilepsy
• history of autonomic nervous system dysfunction (e.g., postural orthostatic tachycardia syndrome).

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami, Plumer Building

Coral Gables, Florida, 33146, United States

Location

Study Officials

• Marlon Wong, PT, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be blinded to which protocol they are receiving during data collection. The investigator responsible for processing HRV data will be blinded to group assignment, and investigators will be blinded to group assignment when conducting qualitative data analysis.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: December 15, 2024
• Primary Completion: June 7, 2025
• Study Completion: June 7, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)